Tetra Bio-Pharma Opens New Subsidiary in Australia and Provides Regulatory Update
Tetra Bio-Pharma Inc. (“Tetra” or the “Company”) (TSX: TBP) (OTCQB: TBPMF) (FRA: JAM1), a leader in cannabinoid-derived drug discovery and development announces the launch of its new wholly owned subsidiary ‘Tetra Bio-Pharma Australia Pty Ltd’ (“TBP-AU”), an Australian-based research company focused on the execution of clinical trials in Australia. This represents Tetra’s second foreign subsidiary and is in line with the Company’s global expansion strategy for QIXLEEF™, and other future drug candidates.
The new subsidiary follows the recent announcement of Tetra’s partnership with Cannvalate Pty Ltd for the performance of clinical trials of Tetra’s drug candidates in Australia. Accordingly, TBP-AU will benefit from a 43.5% tax credit on all money spent on clinical trials in Australia.
“We look forward to working with our strategic partners and building value for our current and future investors. These are very exciting times for us as we continue to drive scientific excellence and deliver on the promise of cannabinoid-derived transformative medicines to improve patient health and quality of life,” said CEO Dr. Guy Chamberland.
Regulatory Update – REDUVO™
The Company is also pleased announce it has completed the Annual Licence Review process for our Health Canada Drug Establishment Licence (DEL) and meets the regulatory requirements of C.01A.009 of the Food and Drug Regulations to maintain our DEL for the distribution of pharmaceuticals, like REDUVO™, in Canada. Any company that intends to distribute pharmaceutical drugs in Canada must obtain a DEL as per Health Canada regulatory requirements.
On December 30, 2020, the Company submitted its first New Drug Submission (NDS) for REDUVO™ to Health Canada to obtain a Drug Identification Number (DIN) for the prescription drug. The Company is in discussions with Health Canada to address final commentary on the submission. REDUVO™ remains a top priority and the Company is ready to launch manufacturing activities as soon as possible following regulatory approval.
About REDUVO™
REDUVO™ is a soft gel capsule used to treat chemotherapy-induced nausea and vomiting (CINV) and weight loss and severe nausea in people living with HIV infection. The active pharmaceutical ingredient in REDUVO™ is dronabinol, also known as THC, a synthetic form of the active natural substance in cannabis.
About Tetra Bio-Pharma
Tetra Bio-Pharma (TSX: TBP) (OTCQB: TBPMF) (FRA: JAM1) is a leader in cannabinoid-derived drug discovery and development with a FDA and a Health Canada cleared clinical program aimed at bringing novel prescription drugs and treatments to patients and their healthcare providers. Their evidence-based scientific approach has enabled them to develop a pipeline of cannabinoid-based drug products for a range of medical conditions, including pain, inflammation, and oncology. With patients at the core of what they do, Tetra Bio-Pharma is focused on providing rigorous scientific validation and safety data required for inclusion into the existing biopharma industry by regulators, physicians and insurance companies.
For more information visit: www.tetrabiopharma.com
Neither the TSX Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Exchange) accepts responsibility for the adequacy or accuracy of this release.
Forward-looking statements
Some statements in this release may contain forward-looking information. All statements, other than of historical fact, that address activities, events or developments that the Company believes, expects or anticipates will or may occur in the future (including, without limitation, statements regarding potential acquisitions and financings) are forward-looking statements. Forward-looking statements are generally identifiable by use of the words “may”, “will”, “should”, “continue”, “expect”, “anticipate”, “estimate”, “believe”, “intend”, “plan” or “project” or the negative of these words or other variations on these words or comparable terminology. Forward-looking statements are subject to a number of risks and uncertainties, many of which are beyond the Company’s ability to control or predict, that may cause the actual results of the Company to differ materially from those discussed in the forward-looking statements. Factors that could cause actual results or events to differ materially from current expectations include, among other things, without limitation, the inability of the Company to obtain sufficient financing to execute the Company’s business plan; competition; regulation and anticipated and unanticipated costs and delays, the success of the Company’s research and development strategies, including the success of this product or any other product, the applicability of the discoveries made therein, the successful and timely completion and uncertainties related to the regulatory process, the timing of clinical trials, the timing and outcomes of regulatory or intellectual property decisions and other risks disclosed in the Company’s public disclosure record on file with the relevant securities regulatory authorities. Although the Company has attempted to identify important factors that could cause actual results or events to differ materially from those described in forward-looking statements, there may be other factors that cause results or events not to be as anticipated, estimated or intended. Readers should not place undue reliance on forward-looking statements. The forward-looking statements included in this news release are made as of the date of this news release and the Company does not undertake an obligation to publicly update such forward-looking statements to reflect new information, subsequent events or otherwise unless required by applicable securities legislation.
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SOURCE Tetra Bio-Pharma Inc.
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